AzTrials
AzTrials

Breast CancerPhase 3NCT00003855

Lymph Node Removal in Treating Women Who Have Stage I or Stage IIA Breast Cancer

A Phase 3 study testing axillary lymph node dissection and whole breast irradiation in people with Breast Cancer, run by Alliance for Clinical Trials in Oncology at 156 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Surgery to remove lymph nodes in the armpit may remove cancer cells that have spread from tumors in the breast. PURPOSE: Randomized phase III trial to determine the effectiveness of removing lymph nodes in the armpit in treating women who have stage I or stage IIA breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
axillary lymph node dissection and whole breast irradiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
605 participants
Where
156 sitesin 4 countries
Study dates
Apr 1999to Feb 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • PLEASE NOTE: Patients registered to this study may undergo intra-operative or post¬operative randomization.
  • Patient must be female.
  • Patient must be at least 18 years of age.
  • Patient's clinical stage must be documented as tumor size less than 5 cm, with no palpable nodes and no evidence of metastatic disease (T1 or T2 N0 M0; see appendices for staging criteria) and the tumor documented as amenable to lumpectomy.
  • Patient must have a tissue diagnosis of invasive breast carcinoma. Note: A patient can be registered to this study if they have a cytologic diagnosis suggestive of carcinoma from a fine needle aspiration (FNA) of a palpable or non-palpable breast lesion and the investigator believes the breast lesion is clinically suspicious for invasive breast carcinoma.
  • Date of the patient's first tissue diagnosis of invasive breast carcinoma or cytologic diagnosis of carcinoma must be no more than 60 days prior to the SLND.
Show all 20Show fewer
  • The patient who had BCT (segmental mastectomy) performed previously, and is now referred to the local investigator for SLND, is eligible if the BCT was less than or equal to 60 days prior to the SLND. NOTE: Copies of the operative and pathology reports must be submitted as part of the registration process.
  • Patient must have ECOG/Zubrod status =2, as documented in patient's medical record.
  • Patient must be available for follow-up.
  • Patient of childbearing potential must have a negative serum or urine pregnancy test within 14 days of beginning study interventions.
  • Patient must have access to radiation therapy.
  • A sentinel lymph node must be identified that contains metastatic breast cancer as documented by frozen section, touch prep, or H\&E staining on permanent section.
  • NOTE: Patients with metastatic breast cancer identified by immunohistochemistry (IHC) are not eligible.
  • Patient randomized to ALND must undergo ALND within 42 days of their SLND.
  • A patient with a history of a previous malignancy is eligible for this study as long as the patient meets the following criteria for a cancer survivor. A cancer survivor is eligible provided that the following criteria are met:
  • The patient has undergone potentially curative therapy for all prior malignancies,
  • There has been no evidence of any prior malignancies for at least five years with no evidence of recurrence (except for effectively treated basal cell or squamous carcinoma of the skin, carcinoma in -situ of the cervix that has been effectively treated by surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral breast treated by surgery alone), and
  • The patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.
  • Patient or the patient's legally acceptable representative must provide a signed and dated written informed consent prior to registration and any study-related procedures.
  • Patient must provide written authorization to allow the use and disclosure of their protected health information. NOTE: This may be obtained in either the study-specific informed consent or in a separate authorization form and must be obtained from the patient prior to study registration.

Who cannot join

  • Patient is lactating (breastfeeding).
  • Patient has been previously treated with chemotherapy, estrogen receptor antagonists (i.e., Tamoxifen) or selective estrogen receptor modulators (SERMs, i.e., Raloxifene) for this invasive breast cancer.
  • Patient has a previously placed pre-pectoral breast implant. NOTE: A subpectoral implant is allowed.
  • Patient has concurrent invasive bilateral breast malignancies.
  • Patient has clinically and radiologically identified multi-centric disease that is not amenable to a single lumpectomy.
  • Patient has had previous ipsilateral axillary surgery such as excisional biopsy of lymph node(s), treatment of hidradenitis.
Show all 9Show fewer
  • Patient has a medical contraindication to ALND or is considered a poor surgical risk due to a non-malignant systemic disease (cardiovascular, renal, etc.) that would preclude the treatment options.
  • Patient who is noted to have matted nodes or gross extranodal disease at the time of SLND.
  • Patient has three or more positive sentinel nodes by frozen section, touch prep, or H\&E staining on permanent section.

Trial locations and contacts

156 sites in 4 countries.

156 sites in 4 countries

United States152 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Study site

    Albany, Georgia, 31701

  • Phoebe Cancer Center at Phoebe Putney Memorial Hospital

    Albany, Georgia, 31702

  • Sacred Heart Hospital

    Allentown, Pennsylvania, 18102

  • John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital

    Allentown, Pennsylvania, 18105-1556

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0001

  • DeCesaris Cancer Institute at Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • Hope A Women's Cancer Center

    Asheville, North Carolina, 28816

  • University of Colorado Cancer Center at University of Colorado Health Sciences Center

    Aurora, Colorado, 80010

  • Seton Shivers Cancer Program at Brackenridge Hospital

    Austin, Texas, 78701

  • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

    Baltimore, Maryland, 21215

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21287

  • Woman's Hospital

    Baton Rouge, Louisiana, 70815

  • Baton Rouge General Regional Cancer Center

    Baton Rouge, Louisiana, 70821-2511

  • St. Francis Hospital and Health Centers

    Beech Grove, Indiana, 46107

  • St. Elizabeth's Hospital

    Belleville, Illinois, 62220-1998

  • Belleville Memorial Hospital

    Belleville, Illinois, 62226-5399

  • St. Luke's Hospital Cancer Center

    Bethlehem, Pennsylvania, 18015

  • University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, 35294-3300

  • St. Luke's Regional Medical Center

    Boise, Idaho, 83712

  • Lutheran Medical Center

    Brooklyn, New York, 11220

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Mercy San Juan Hospital

    Carmichael, California, 95608

  • Blumenthal Cancer Center at Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Cancer Center at the University of Virginia

    Charlottesville, Virginia, 22908

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • John H. Stroger, Jr. Hospital of Cook County

    Chicago, Illinois, 60612-9985

  • Carilion New River Valley Medical Center

    Christiansburg, Virginia, 24073

  • Tri-Health Good Samaritan Hospital

    Cincinnati, Ohio, 90027

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University

    Cleveland, Ohio, 44106-5065

  • Memorial Hospital Cancer Center

    Colorado Springs, Colorado, 80909

  • Arrowhead Regional Medical Center

    Colton, California, 92324-1819

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • Arthur G. James Cancer Hospital at Ohio State University

    Columbus, Ohio, 43210-1240

  • Mount Diablo Regional Cancer Center

    Concord, California, 94524-4110

  • Louis Busch Hager Cancer Center at Mary Imogene Bassett Hospital

    Cooperstown, New York, 13326

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Zale Lipshy University Hospital

    Dallas, Texas, 75235-7707

  • Parkland Health and Hospital System

    Dallas, Texas, 75235-7786

  • St. Paul University Hospital

    Dallas, Texas, 75235

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas

    Dallas, Texas, 75390-9155

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-2001

  • Good Samaritan Hospital

    Dayton, Ohio, 45406-1891

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Charles B. Eberhart Cancer Center at DeKalb Medical Center

    Decatur, Georgia, 30033

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Josephine Ford Cancer Center at Henry Ford Health System

    Detroit, Michigan, 48202

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Easton Hospital

    Easton, Pennsylvania, 18042

  • Alexian Brothers Medical Center

    Elk Grove Village, Illinois, 60007

  • Evanston Northwestern Health Care - Evanston Hospital

    Evanston, Illinois, 60201

  • Deaconess Hospital

    Evansville, Indiana, 47747

  • St. Mary's Medical Center

    Evansville, Indiana, 47750

  • INOVA Fair Oaks Hospital

    Fairfax, Virginia, 22033

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042-3300

  • Washington Regional Medical Center

    Fayetteville, Arkansas, 72703

  • Great Lakes Cancer Institute - McLaren

    Flint, Michigan, 48532

  • Surgical Oncology of Northeast Georgia

    Gainesville, Georgia, 30501

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0542

  • Genesys Regional Medical Center

    Grand Blanc, Michigan, 48439-8066

  • Butterworth Hospital

    Grand Rapids, Michigan, 49503

  • Spectrum Health Downtown Campus

    Grand Rapids, Michigan, 49503

  • Spectrum Health - Blodgett Campus

    Grand Rapids, Michigan, 49506

  • St. Francis Medical Center

    Honolulu, Hawaii, 96817

  • Kaiser Permanente Medical Center

    Honolulu, Hawaii, 96819

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Baylor University Medical Center - Houston

    Houston, Texas, 77030

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • Keesler Medical Center - Keesler Air Force Base

    Keesler Air Force Base, Mississippi, 39534-2576

  • Kingston Hospital

    Kingston, New York, 12401-4692

  • Fern Feldman Anolick Breast Center at Benedictine Hospital

    Kingston, New York, 12401

  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Lakeland Regional Cancer Center at Lakeland Regional Medical Center

    Lakeland, Florida, 33804-1057

  • Watson Clinic

    Lakeland, Florida, 33805

  • Doctor's Hospital of Laredo

    Laredo, Texas, 78045

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • Central Baptist Hospital

    Lexington, Kentucky, 40503-9985

  • St. Vincent Doctors Doctors Hospital

    Little Rock, Arkansas, 72205-5331

  • Baptist Health Medical Center

    Little Rock, Arkansas, 72205-7200

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Loma Linda University Cancer Institute at Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Norton Healthcare Cancer Center

    Louisville, Kentucky, 40202-5070

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas, 79410-1894

  • Southwest Cancer and Research Center at University Medical Center

    Lubbock, Texas, 79415-3364

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792-7375

  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital

    Marlton, New Jersey, 08053

  • Baptist Cancer Institute at Baptist Memorial Hospital - Memphis

    Memphis, Tennessee, 38120

  • Middletown Regional Hospital

    Middletown, Ohio, 45044-4898

  • Vince Lombardi Cancer Clinic at St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215-5166

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

  • Providence Cancer Center

    Mobile, Alabama, 36608

  • Mobile Infirmary Medical Center

    Mobile, Alabama, 36640-0460

  • West Virginia University Hospitals

    Morgantown, West Virginia, 26506-9300

  • Morristown Memorial Hospital

    Morristown, New Jersey, 07962-1956

  • Cottonwood Hospital Medical Center

    Murray, Utah, 84107

  • Southern New Hampshire Medical Center

    Nashua, New Hampshire, 03061-2014

  • Sarah Cannon Cancer Center at Centennial Medical Center

    Nashville, Tennessee, 37203

  • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

    Nashville, Tennessee, 37232-6860

  • Baptist Hospital

    Nashville, Tennessee, 37236

  • New York Weill Cornell Cancer Center at Cornell University

    New York, New York, 10021-4885

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Summit Medical Center

    Oakland, California, 94609

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • St. Joseph Hospital Regional Cancer Center - Orange

    Orange, California, 92868-3849

  • Palo Alto Medical Foundation

    Palo Alto, California, 94301

  • Huntington Cancer Center at Huntington Hospital

    Pasadena, California, 91105

  • Regional Cancer Center at Singing River Hospital

    Pascagoula, Mississippi, 39581

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-4283

  • UPMC Cancer Center at Magee-Womens Hospital

    Pittsburgh, Pennsylvania, 15213

  • Mercy Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15219

  • Maine Medical Center

    Portland, Maine, 04102

  • Kaiser Permanente Medical Office - Mother Joseph Plaza

    Portland, Oregon, 97225

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Women and Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905

  • Shasta Regional Medical Center

    Redding, California, 96001-0853

  • Carilion Health System - Cancer Center of Western Virginia

    Roanoke, Virginia, 24033

  • Highland Hospital of Rochester

    Rochester, New York, 14620

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • Park Nicollet Clinic

    Saint Louis Park, Minnesota, 55416

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84132

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94115

  • John Wayne Cancer Institute at Saint John's Health Center

    Santa Monica, California, 90404

  • CCOP - Mayo Clinic Scottsdale Oncology Program

    Scottsdale, Arizona, 85259-5404

  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98122-4307

  • Sonoma Valley Hospital

    Sonoma, California, 95476

  • Hulston Cancer Center at Cox Medical Center South

    Springfield, Missouri, 65807-1988

  • St. Louis University Hospital Cancer Center

    St Louis, Missouri, 63110-0250

  • Siteman Cancer Center at Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Dixie Regional Medical Center

    St. George, Utah, 84770

  • Mount Nittany Medical Center

    State College, Pennsylvania, 16803

  • St. Joseph's Regional Cancer Center

    Stockton, California, 95204

  • Martin Memorial Cancer Center

    Stuart, Florida, 34995-9010

  • Flower Hospital - ProMedica Health System

    Sylvania, Ohio, 43560

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612-9497

  • Comprehensive Cancer Center at Our Lady of Mercy Medical Center

    The Bronx, New York, 10466

  • Toledo Hospital

    Toledo, Ohio, 43606

  • St. Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • UVMC Cancer Care Center at Upper Valley Medical Center

    Troy, Ohio, 45373-1300

  • Lombardi Cancer Center at Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Henry Ford Medical Center - West Bloomfield

    West Bloomfield, Michigan, 48322

  • Williamsport Hospital

    Williamsport, Pennsylvania, 17701-1995

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1082

  • Fallon Clinic at Worcester Medical Center

    Worcester, Massachusetts, 01608

  • Greene Memorial Hospital

    Xenia, Ohio, 45385

  • Avera Sacred Heart Hospital

    Yankton, South Dakota, 57078

Other trials in United States

Ireland2 sites

  • Cork University Hospital

    Cork

  • St. Vincent's University Hospital

    Dublin, 4

Other trials in Ireland

Australia1 site

  • Peter MacCallum Cancer Centre

    East Melbourne, Victoria, 3002

Other trials in Australia

Canada1 site

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

Official title: A Randomized Trial of Axillary Node Dissection in Women With Clinical T1-2 N0-1 M0 Breast Cancer Who Have a Positive Sentinel Node

RATIONALE: Surgery to remove lymph nodes in the armpit may remove cancer cells that have spread from tumors in the breast.

PURPOSE: Randomized phase III trial to determine the effectiveness of removing lymph nodes in the armpit in treating women who have stage I or stage IIA breast cancer.

Read the detailed description

OBJECTIVES:

Primary objectives:

Long term: To assess whether overall survival for patients randomized to Arm 2 (no immediate ALND) is essentially equivalent to (or better than) than that for patients assigned to Arm 1 (completion ALND).

Short term: To quantify and compare the surgical morbidities associated with SLND plus ALND versus SLND alone.

OUTLINE: This is a randomized study. After segmental mastectomy and sentinel lymph node dissection, patients are stratified according to age (50 and under vs over 50), estrogen receptor status (positive vs negative), and tumor size (no greater than 1 cm vs greater than 1 cm but no greater than 2 cm vs greater than 2 cm). Patients are randomized to one of two treatment arms.

Conditions
Breast Cancer
Being tested
axillary lymph node dissection, whole breast irradiation
Keywords
stage IA breast cancer, stage IB breast cancer, stage II breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • axillary lymph node dissectionProcedure or surgery

  • whole breast irradiationRadiation

Study groups in NCT00003855
Study groupRoleWhat they receive
Surgery + radiotherapyExperimentalPatients undergo axillary lymph node dissection involving removal of at least level I and II nodes, followed by whole-breast radiotherapy (exclusive of a third supraclavicular field) 5 days a week for a maximum of 7 weeks. Patients may receive adjuvant systemic therapy at the discretion of the treating physician. Patients are followed up at 30 days, at 6, 12, 18, 30, and 36 months, and then annually for a total of 10 years.
Receives: Procedure: axillary lymph node dissection; Radiation: whole breast irradiation
RadiotherapyActive comparatorPatients undergo breast radiotherapy only. Patients may receive adjuvant systemic therapy at the discretion of the treating physician. Patients are followed up at 30 days, at 6, 12, 18, 30, and 36 months, and then annually for a total of 10 years.
Receives: Radiation: whole breast irradiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Measured: Up to 10 years

  2. Morbidity

    Measured: Up to 10 years

  3. Disease-free survival

    Measured: Up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startApr 1999
  3. Primary completionAug 2007
  4. Study completionFeb 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
605 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003855
Sponsor's protocol ID
ACOSOG-Z0011
Other IDs
GUMC-00153, CDR0000067018
Status last verified
Apr 2020
First submitted
1 Nov 1999
Last updated
29 Apr 2020
Results posted
No
Data monitoring committee
No

Publications

  • Ainsworth RK, Kollias J, Le Blanc A, De Silva P. The clinical impact of the American College of Surgeons Oncology Group Z-0011 trial--results from the BreastSurgANZ National Breast Cancer Audit. Breast. 2013 Oct;22(5):733-5. doi: 10.1016/j.breast.2012.11.005. Epub 2013 Jan 2.

    PubMed 23290275

  • Gainer SM, Hunt KK, Beitsch P, Caudle AS, Mittendorf EA, Lucci A. Changing behavior in clinical practice in response to the ACOSOG Z0011 trial: a survey of the American Society of Breast Surgeons. Ann Surg Oncol. 2012 Oct;19(10):3152-8. doi: 10.1245/s10434-012-2523-z. Epub 2012 Jul 21.

    PubMed 22820938

  • Olson JA Jr, McCall LM, Beitsch P, Whitworth PW, Reintgen DS, Blumencranz PW, Leitch AM, Saha S, Hunt KK, Giuliano AE; American College of Surgeons Oncology Group Trials Z0010 and Z0011. Impact of immediate versus delayed axillary node dissection on surgical outcomes in breast cancer patients with positive sentinel nodes: results from American College of Surgeons Oncology Group Trials Z0010 and Z0011. J Clin Oncol. 2008 Jul 20;26(21):3530-5. doi: 10.1200/JCO.2007.15.5630.

    PubMed 18640934

  • Leitch AM, McCall L, Beitsch P, et al.: Factors influencing accrual to ACOSOG Z0011, a randomized phase III trial of axillary dissection vs. observation for sentinel node positive breast cancer. [Abstract] J Clin Oncol 24 (Suppl 18): A-601, 2006.

  • Krishnan MS, Recht A, Bellon JR, Punglia RS. Trade-offs associated with axillary lymph node dissection with breast irradiation versus breast irradiation alone in patients with a positive sentinel node in relation to the risk of non-sentinel node involvement: implications of ACOSOG Z0011. Breast Cancer Res Treat. 2013 Feb;138(1):205-13. doi: 10.1007/s10549-013-2418-0. Epub 2013 Jan 22.

    PubMed 23338762

  • Shah-Khan M, Boughey JC. Evolution of axillary nodal staging in breast cancer: clinical implications of the ACOSOG Z0011 trial. Cancer Control. 2012 Oct;19(4):267-76. doi: 10.1177/107327481201900403.

    PubMed 23037494

  • Caudle AS, Hunt KK, Kuerer HM, Meric-Bernstam F, Lucci A, Bedrosian I, Babiera GV, Hwang RF, Ross MI, Feig BW, Hoffman K, Litton JK, Sahin AA, Yang W, Hortobagyi GN, Buchholz TA, Mittendorf EA. Multidisciplinary considerations in the implementation of the findings from the American College of Surgeons Oncology Group (ACOSOG) Z0011 study: a practice-changing trial. Ann Surg Oncol. 2011 Sep;18(9):2407-12. doi: 10.1245/s10434-011-1593-7. No abstract available.

    PubMed 21327455

  • Giuliano AE, Hunt KK, Ballman KV, Beitsch PD, Whitworth PW, Blumencranz PW, Leitch AM, Saha S, McCall LM, Morrow M. Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial. JAMA. 2011 Feb 9;305(6):569-75. doi: 10.1001/jama.2011.90.

    PubMed 21304082

  • Giuliano AE, McCall L, Beitsch P, Whitworth PW, Blumencranz P, Leitch AM, Saha S, Hunt KK, Morrow M, Ballman K. Locoregional recurrence after sentinel lymph node dissection with or without axillary dissection in patients with sentinel lymph node metastases: the American College of Surgeons Oncology Group Z0011 randomized trial. Ann Surg. 2010 Sep;252(3):426-32; discussion 432-3. doi: 10.1097/SLA.0b013e3181f08f32.

    PubMed 20739842

  • Lucci A, McCall LM, Beitsch PD, Whitworth PW, Reintgen DS, Blumencranz PW, Leitch AM, Saha S, Hunt KK, Giuliano AE; American College of Surgeons Oncology Group. Surgical complications associated with sentinel lymph node dissection (SLND) plus axillary lymph node dissection compared with SLND alone in the American College of Surgeons Oncology Group Trial Z0011. J Clin Oncol. 2007 Aug 20;25(24):3657-63. doi: 10.1200/JCO.2006.07.4062. Epub 2007 May 7.

    PubMed 17485711

  • Giuliano AE, Ballman KV, McCall L, Beitsch PD, Brennan MB, Kelemen PR, Ollila DW, Hansen NM, Whitworth PW, Blumencranz PW, Leitch AM, Saha S, Hunt KK, Morrow M. Effect of Axillary Dissection vs No Axillary Dissection on 10-Year Overall Survival Among Women With Invasive Breast Cancer and Sentinel Node Metastasis: The ACOSOG Z0011 (Alliance) Randomized Clinical Trial. JAMA. 2017 Sep 12;318(10):918-926. doi: 10.1001/jama.2017.11470.

    PubMed 28898379

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing axillary lymph node dissection and whole breast irradiation in people with Breast Cancer, run by Alliance for Clinical Trials in Oncology at 156 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 156 sites in United States, Ireland, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: Up to 10 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003855, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020.

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